Scientific Director, Medical Affairs - Migraine

AbbVie Inc.; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking a Scientific Director to provide medical and scientific strategic input into medical affairs activities, including interactions with healthcare professionals, generation of data, education initiatives, and safety surveillance. You will work with commercial teams to align medical input with brand strategies and support product launches.

The role requires an advanced degree and 5–7+ years in pharma, with strong knowledge of clinical trial methodology and regulatory requirements.

Qualifications

• Advanced degree (PhD, PharmD, PA or NP preferred).
• 5–7+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area preferred.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and product approval, and experience in design of protocols preferred.
• Interactions normally required the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and topics to varied audiences, and persuade without authority.
• Ability to interact with internal and external stakeholders to support global business strategy. Must possess excellent oral and written communication skills.
• May coordinate appropriate scientific and medical activities with internal stakeholders including commercial, clinical ops, discovery, stats, regulatory, etc., as they relate to ongoing Medical Affairs projects.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
• Works with some supervision and guidance. Exercises judgement within well-defined practices and policies.

Responsibilities

• With oversight, contributes to the development of brand strategies. Actively contributes to thee development of a TA EE Engagement Plan.
• Leads and supports Medical Affairs initiatives for the target indication.
• Develops and executes Medical affairs support of priority clinical development trials.
• Contributes to the development of and leads the execution of Medical Education / Advisory Boards as needed; Lead conference planning and execution.
• Generates clinical and scientific data per evidence gap assessment.
• Responsible to manage budget for assigned projects.
• Aligns Medical education and scientific initiatives with the Scientific Communication Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IIS submissions.
• Contributes to the generation of Medical Information communication content and supports training on Medical Information materials.
• Participates in design and execution of clinical trial safety, product safety and risk management plans. Track Risk Mitigation Plan (RMP) implementation.
• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

Skills

Medical affairs

Stakeholder management

Clinical trials

Regulatory knowledge

Communication skills

Presentation skills

Cross-functional coordination

Education

Advanced degree (PhD/PharmD/PA/NP)

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

The Scientific Director provides medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); education initiatives (medical education, data, society guidelines, and value proposition); safeguarding patient safety (risk minimization and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access. Collaborates with clin8ical development on Medical Affairs support of priority trials.

Responsibilities:

• With oversight, contributes to the development of brand strategies. Actively contributes to thee development of a TA EE Engagement Plan.

• Leads and supports Medical Affairs initiatives for the target indication.

• Develops and executes Medical affairs support of priority clinical development trials.

• Contributes to the development of and leads the execution of Medical Education / Advisory Boards as needed; Lead conference planning and execution.

• Generates clinical and scientific data per evidence gap assessment.

• Responsible to manage budget for assigned projects.

• Aligns Medical education and scientific initiatives with the Scientific Communication Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IIS submissions.

• Contributes to the generation of Medical Information communication content and supports training on Medical Information materials.

• Participates in design and execution of clinical trial safety, product safety and risk management plans. Track Risk Mitigation Plan (RMP) implementation.

• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

Qualifications

• Advanced Degree (PhD, PharmD, PA or NP preferred)

• 5-7+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area preferred.

• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and product approval, and experience in design of protocols preferred.

• Interactions normally required the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and topics to varied audiences, and persuade without authority.

• Ability to interact with internal and external stakeholders to support global business strategy. Must possess excellent oral and written communication skills.

• May coordinate appropriate scientific and medical activities with internal stakeholders including commercial, clinical ops, discovery, stats, regulatory, etc., as they relate to ongoing Medical Affairs projects.

• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.

• Works with some supervision and guidance. Exercises judgement within well-defined practices and policies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinate. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html